Quốc gia: Malta
Ngôn ngữ: Tiếng Anh
Nguồn: Medicines Authority
KETOPROFEN LYSINE
Dompe Farmaceutici SpA Via San Martino 12, 20122, Milan, Italy
M01AE03
KETOPROFEN LYSINE 60 mg
SUPPOSITORY
KETOPROFEN LYSINE 60 mg
POM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Withdrawn
2009-01-21
Insert leaflet OKI 60 MG SUPPOSITORIES M01AE03 Ketoprofen lysine salt COMPOSITION One suppository contains: ketoprofen lysine salt, 60 mg. Excipients: semi-synthetic glycerides. PHARMACEUTICAL FORM AND PRESENTATION Suppositories. Box of 10 suppositories. THERAPEUTIC CLASS Non-steroidal anti-inflammatory. MARKETING AUTHORISATION HOLDER IN ITALY Dompé farmaceutici S.p.A., Via San Martino 12 20122 Milano Italy. MANUFACTURER Istituto De angeli s.r.l. – Pharmaceutical plant Reggello (FI) INDICATIONS Symptomatic and short-term treatment of inflammatory conditions associated with pain, such as those affecting the osteoarticular apparatus, post-operational pain and otitis. CONTRAINDICATIONS Active peptic ulcer or an history of gastrointestinal bleeding, ulceration or perforation related to previous active treatment or history of recurrent haemorrhage/peptic ulcer (two or more different episodes of ulceration or haemmorrage demonstrated) or chronic dyspepsia. Gastritis, serious renal failure, leukopenia and thrombocytopenia, serious blood clotting disorders, colitis ulcerative and serious heart failure _HYPERSENSITIVITY TO KETOPROFEN. _ There is the risk of cross-hypersensitivity reactions with acetylsalycilic acid or other non-steroidal anti-inflammatory drugs. For this reason ketoprofen should not be given to patients in whom acetylsalycilic acid or other non-steroidal anti-inflammatory drugs have caused the appearance of symptoms of asthma, rhinitis, urticaria. Children under 6 years old. WARNINGS AND PRECAUTIONS FOR USE The use of OKi 60 mg suppositories with concomitant NSAIDS, including cyclooxygenase-2 selective should be avoid. Undesiderables effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms. Gastrointestinal bleeding, ulceration and perforation: gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDS at any time during treatment, with or without warning symptoms or a previous history of seriou Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT OKi 60 mg suppositories OKi 30 mg suppositories 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Suppositories 60 30 Each suppository contains: Active ingredient: Ketoprofen lysine salt 60 mg 30 mg 3. PHARMACEUTICAL FORM Suppositories 4. CLINICAL INFORMATION _4.1 THERAPEUTIC INDICATIONS _ Symptomatic and short-term treatment of painful inflammatory conditions such as those affecting the osteoarticular system, post-operative pain and otitis. _4.2 DOSAGE AND METHOD OF ADMINISTRATION _ As the recommended dose should be between 1 and 2 mg/Kg per administration, the following dosage regimen is recommended: children aged over 6 years: - body weight of less than 30 Kg: 1 OKi 30 mg suppository 2-3 times a day - body weight of more than 30 Kg: 1 OKi 60 mg suppository 2-3 times a day. _4.3 CONTRAINDICATIONS _ Active peptic ulcer or an history of gastrointestinal bleeding, ulceration or perforation related to previous active treatment or history of recurrent haemorrhage/peptic ulcer (two or more different episodes of ulceration or haemmorrage demonstrated) or chronic dyspepsia. Gastritis, serious renal failure, leukopenia and thrombocytopenia, serious blood clotting disorders and serious heart failure. _HYPERSENSITIVITY TO KETOPROFEN. _ There is the risk of cross-hypersensitivity reactions with acetylsalycilic acid or other nonsteroidal anti-inflammatory drugs. For this reason ketoprofen should not be given to patients in whom acetylsalycilic acid or other non-steroidal anti-inflammatory drugs have caused the appearance of symptoms of asthma, rhinitis, urticaria. Children aged under 6 years. _4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE _ The use of OKi 60 mg suppositories and Oki 30 mg suppositories with concomitant NSAIDS, including cyclooxygenase-2 selective should be avoid. Undesiderables effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms (see section 4.2 and the below paragraphs on gastrointe Đọc toàn bộ tài liệu